Technology ID
TAB-5042

Detection of Hepatitis C Virus for point of care kit

E-Numbers
E-064-2023-0
Lead Inventor
Pauly, Matthew (CDC)
Co-Inventors
Kamili, Saleem (CDC)
Mixson-Hayden, Tonya (CDC)
Ganova-Raeva, Lilia (CDC)
Weis Torres, Sabrina (CDC)
Applications
Diagnostics
Therapeutic Areas
Infectious Disease
Development Stages
Pre-Clinical (in vitro)
Development Status
In vitro data available
ICs
CDC

Hepatitis C virus (HCV) is a major global health problem with an estimated 58 million infections in 2019.  However, most HCV infections go undiagnosed due to the lack of clinical symptoms or for lack of access to simple and affordable diagnostic testing. It is estimated that only 21% and 61% of people with a chronic HCV infection have been diagnosed, worldwide and in the United States, respectively.

This technology provides simple and rapid workflows for processing whole blood samples for the detection of hepatitis C virus (HCV). Each of these workflows precedes nucleic acid amplification using reverse transcription loop-mediated isothermal amplification (RT-LAMP).  A set of novel primers allow for robust and rapid nucleic acid amplification from the six most common HCV genotypes. Each workflow allows for streamlined and sensitive detection of HCV RNA from whole blood samples in less than 60 minutes.  These workflows, in combination with procedural simplifications, could allow for simple, rapid, inexpensive, and sensitive diagnosis of current HCV infection at or near the point of care.  

Commercial Applications
  • Point of care diagnostics.
  • Automated analytical detection devices.
Competitive Advantages
  • Current testing for HCV RNA is performed at a site that is distant from the site of sample collection, this technology would allow for rapid point of care detection.
Licensing Contact:
Flammang, Ann Marie
annmarie.flammang@nih.gov